Effectiveness of Localized Prostate Cancer Treatments

NCT01492751 | Active Not Recruiting

• 1 other identifier: CaProst 2002
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to evaluate the effectiveness of the three most established primary treatments for patients with clinically localized prostate cancer (radical prostatectomy, external-beam radiotherapy, and prostate brachytherapy) at short, mid and long-term follow-up. The primary aim is assessing Quality of Life impact of treatments' side effects. As secondary objectives biochemical disease-free survival, overall survival, and prostate cancer-specific survival will be also assessed.

Conditions

Prostate Cancer

Keywords

Prostatic Neoplasms; Radiotherapy conformal; brachytherapy; radical prostatectomy; Quality of life; biochemical relapse; biochemical failure; survival; Clinically localized prostate cancer

Outcome Measures

Primary Outcomes (1)

• Quality of Life impact of treatments' side effects measured by change in the Expanded Prostate Cancer Index Composite (EPIC) score from baseline to 2, 5, 7 and 10 years after treatment and every 5 years thereafter.

  The Expanded Prostate Cancer Index Composite (EPIC) is a prostate cancer specific questionnaire constructed by expanding the UCLA-PCI to assess function and bother in the 4 domains: Urinary, Bowel, Sexual, and Hormonal.For each domain a summary score is constructed. In addition, two urinary scales that distinguish irritative/obstructive symptoms and incontinence are developed by the authors of the questionnaire. The 50 EPIC items are answered on a 5-point Likert scale and these are transformed linearly to obtain scores ranging from 0-100, with higher scores indicating better Quality of Life.

  2, 5, 7 and 10 years after treatment and every 5 years thereafter.

Secondary Outcomes (10)

• Biochemical disease-free survival

  5, 7 and 10 years after treatment and every 5 years thereafter.

• Overall survival

  5, 7 and 10 years after treatment and every 5 years thereafter.

• Prostate cancer-specific survival

  10 years after treatment and then every 5 years thereafter.

• Disease-Free Survival

  10 years after treatment and every 5 years thereafter.

• Perceived general health measured by the Medical Outcomes Study 36-Item Short Form (SF-36).

  2, 5, 7 and 10 years after treatment and then every 5 years thereafter.

Study Arms (1)

Spanish Multicentric Clinically Localized Prostate Cancer

A consecutive sample of clinically localized prostate cancer patients treated with radical prostatectomy, external beam radiotherapy and prostate brachytherapy in 10 Spanish hospitals.

Behavioral: Quality of life assessment and Clinical evaluation; Procedure: Radical retropubic prostatectomy surgery; Radiation: External beam radiotherapy; Radiation: Prostate Brachytherapy

Interventions

Quality of life assessment and Clinical evaluation BEHAVIORAL

quality of life assessed by the Expanded Prostate Cancer Index Composite (EPIC), the Medical Outcomes Study 36-Item Short Form (SF-36) version 2, the Functional Assessment of cancer Therapy, General and Prostate specific (FACT-G and FACT-P, respectively), the International Prostate Symptom Score (IPSS), and the International Index of Erectile Function (IIES). Quality of Life questionnaires are administered centrally by telephone interview before treatment and during follow-up at 1, 3, 6, and 12 months after treatment the first year, then annually until 10 years, and every 5 years thereafter. Demographic and clinical characteristics at baseline are recorded at clinical sites and include age, Prostate Specific Antigen (PSA), Gleason grading, prostate volume, risk group and use of neoadjuvant hormonal treatment. According tho the national health guidelines participants are visited every 6-12 months after treatment.

Spanish Multicentric Clinically Localized Prostate Cancer

Radical retropubic prostatectomy surgery PROCEDURE

The surgery group underwent radical retropubic prostatectomy. The surgery is performed by a technique based on a modification of the radical retropubic prostatectomy described by Walsh. The prostatectomy is performed in retrograde way, preserving the neurovascular bundles if feasible, controlling the vessels with titanium clips, and avoiding any kind of coagulation to decrease the risk of neurovascular bundle damage. The bladder neck may be preserved on surgeon criteria. Lymph node dissection is rarely performed due to the extremely low risk of metastatic involvement in this subset of patients. The operative time is about 2 to 3 hours and required hospital stay. The patient has a urinary catheter placed for 1 to 3 weeks to facilitate bladder emptying.

Spanish Multicentric Clinically Localized Prostate Cancer

External beam radiotherapy RADIATION

External beam radiation is carried out with the 3D conformal technique. Patients are treated in a supine position by immobilizing feet and legs. Data from a computed tomography (CT) scan performed with the patient in the treatment position were entered into a 3D treatment-planning system to outline prostate, bladder, and rectum on each slice. Seminal vesicles and regional lymphatics are also contoured if a high risk of involvement was suspected. Applied margins are used to calculate prostate planning target volume (PTV). Custom blocking with Cerrobend blocks or multileaf collimators are designed using beam's eye view, and additional margins were adjusted to provide a minimum dose of 95% to the prostate PTV. Treatment is delivered in 1.8 to 2.0 Gy daily fractions, 5 days per week. Off-line setup control is assessed weekly by comparing orthogonal portal images with the corresponding digitally reconstructed radiographs.

Spanish Multicentric Clinically Localized Prostate Cancer

Prostate Brachytherapy RADIATION

Brachytherapy is performed by pre-planned procedure. Under epidural anaesthesia, the patient is placed in the lithotomy position (forced lithotomy position larger prostate volumes) and, after probing the patient, the best prostate spatial location is searched, proceeding then to prepare the sterile field and bladder catheterization. A prostate volumetry with a three-dimensional reconstruction is performed and automatically transferred to the scheduler, which processes the images and outlines the prostate, urethra and rectum in each of the sections. In LDR prostate brachytherapy, the prostate gland corresponds to the PTV. The standard dose for 100% isodose is 145 Gy according to the TG-T43 for I-125 sources. Dosimetry calculation of the automatically prescribed dosage is then estimated, with a final manual optimization.

Spanish Multicentric Clinically Localized Prostate Cancer

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinically localized prostate cancer.

You may qualify if:

• Stage T1 or T2, treated with radical retropubic prostatectomy, external beam radiotherapy, or interstitial brachytherapy

You may not qualify if:

• Previous prostate transurethral resection
• Treated in other hospitals out of the participating centers

Sponsors & Collaborators

• Fundacion IMIM: lead

Study Sites (10)

Instituto Catalán de Oncología

Hospitalet Llobregat,, Barcelona, 08908,, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Capio Hospital General de Cataluña

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Instituto Oncológico de Gipuzkoa

San Sebastián, Guipuzcoa, 20012, Spain

Location

Centro Oncológico de Galicia

A Coruña, 15009, Spain

Location

Fundació Puigvert

Barcelona, 08025, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hospital Ramon Y Cajal

Madrid, 28034, Spain

Location

Hospital Regional Carlos Haya

Málaga, 29010, Spain

Location

Hospitales Universitarios Virgen Del Rocío

Seville, 41013, Spain

Location

Related Publications (7)

• Ferrer M, Suarez JF, Guedea F, Fernandez P, Macias V, Marino A, Hervas A, Herruzo I, Ortiz MJ, Villavicencio H, Craven-Bratle J, Garin O, Aguilo F; Multicentric Spanish Group of Clinically Localized Prostate Cancer. Health-related quality of life 2 years after treatment with radical prostatectomy, prostate brachytherapy, or external beam radiotherapy in patients with clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Oct 1;72(2):421-32. doi: 10.1016/j.ijrobp.2007.12.024. Epub 2008 Mar 5.

  PMID: 18325680 RESULT

• Becerra Bachino V, Cots F, Guedea F, Pera J, Boladeras A, Aguilo F, Suarez JF, Gallo P, Murgui L, Pont A, Cunillera O, Pardo Y, Ferrer M; Grupo Multicentrico Espanol de Cancer de Prostata Organoconfinado. [Cost comparison of three treatments for localized prostate cancer in Spain: radical prostatectomy, prostate brachytherapy and external 3D conformal radiotherapy]. Gac Sanit. 2011 Jan-Feb;25(1):35-43. doi: 10.1016/j.gaceta.2010.10.008. Spanish.

  PMID: 21316126 RESULT

• Ferrer M, Garin O, Pera J, Prats JM, Mendivil J, Alonso J, De Paula B, Herruzo I, Hervas A, Macias V, Marino A, Ortiz MJ, Pastor S, Ponce De Leon J, Sancho G; el Grupo Multicentrico Espanol de Cancer de Prostata Localizado. [Evaluation of the quality of life of patients with localizad prostate cancer: validation of the Spanish version of the EPIC]. Med Clin (Barc). 2009 Feb 7;132(4):128-35. doi: 10.1016/j.medcli.2008.01.001. Epub 2009 Feb 4. Spanish.

  PMID: 19211071 RESULT

• Guedea F, Ferrer M, Pera J, Aguilo F, Boladeras A, Suarez JF, Cunillera O, Ferrer F, Pardo Y, Martinez E, Ventura M. Quality of life two years after radical prostatectomy, prostate brachytherapy or external beam radiotherapy for clinically localised prostate cancer: the Catalan Institute of Oncology/Bellvitge Hospital experience. Clin Transl Oncol. 2009 Jul;11(7):470-8. doi: 10.1007/s12094-009-0387-x.

  PMID: 19574206 RESULT

• Garin O, Suarez JF, Guedea F, Pont A, Pardo Y, Goni A, Marino A, Hervas A, Herruzo I, Cabrera P, Sancho G, Ponce de Leon J, Macias V, Gutierrez C, Castells M, Ferrer M; Multicentric Spanish Group of Clinically Localized Prostate Cancer. Comparative Effectiveness Research in Localized Prostate Cancer: A 10-Year Follow-up Cohort Study. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):718-726. doi: 10.1016/j.ijrobp.2020.12.032. Epub 2021 Jan 1.

  PMID: 33388360 RESULT

• Suarez JF, Zamora V, Garin O, Gutierrez C, Pont A, Pardo Y, Goni A, Marino A, Hervas A, Herruzo I, Cabrera P, Sancho G, Ponce de Leon J, Macias V, Guedea F, Vigues F, Castells M, Ferrer M; Multicentric Spanish Group of Clinically Localized Prostate Cancer. Mortality and biochemical recurrence after surgery, brachytherapy, or external radiotherapy for localized prostate cancer: a 10-year follow-up cohort study. Sci Rep. 2022 Jul 22;12(1):12589. doi: 10.1038/s41598-022-16395-w.

  PMID: 35869124 RESULT

• Zamora V, Garin O, Suarez JF, Guedea F, Pont A, Pardo Y, Goni A, Marino A, Hervas A, Herruzo I, Cabrera P, Sancho G, Ponce de Leon J, Macias V, Gutierrez C, Castells M, Ferrer M; Multicenter Spanish Group for Clinically Localized Prostate Cancer. Twenty-year Patient-reported Outcomes After Surgery, Radiotherapy, or Brachytherapy for Localized Prostate Cancer. Eur Urol Open Sci. 2025 Nov 9;82:160-167. doi: 10.1016/j.euros.2025.10.007. eCollection 2025 Dec.

  PMID: 41311640 DERIVED

Related Links

• webpage of the coordinator institution: Hospital del Mar Research Institute

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Montserrat Ferrer Fores, PhD, MD

  Fundacio IMIM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 15, 2011
• Study Start: April 1, 2003
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

ES (10)